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CleanImplant Newsletter #1 - 2018

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Content:
-  Editorial
-  How Safe is Your Implant?

Editorial

Dear colleagues, friends and supporters

The first year of CleanImplant Foundation´s activities is over – time to look back on our achievements and events in 2017 and to give an outlook for 2018.

First of all, on behalf of the CleanImplant team and the entire Scientific Advisory Board, we would like to express our thanks for the overwhelming feedback from dentists and implantologists from all around the world. During the year, we received a lot of praise for tackling the problem of remarkable quality differences of dental implants worldwide. And, to be honest, we had to face – somewhat not unexpectedly – a few attempts of intimidation.

You all carry a high degree of responsibility as a dentist – responsibility that the manufacturers of medical devices of questionable quality will not relieve you if it comes to an early peri-implantitis, to unexpected bone loss or even to the loss of the inserted implants due to a possible contamination. Your patients trust in you to use the best possible medical devices and materials.

The newly introduced "Trusted Quality" award should help you to live up to this trust.  Throughout the coming year, we will continue the important work of identifying contaminated implants on the market and providing a platform for those implants that have rigorously proven to be largely free of avoidable contaminants.

You can help us – in a mutual interest for a good cause. Talk about our project. Forward this newsletter and raise the awareness for clean implants among colleagues. 

With best wishes for the New Year

Yours sincerely
Dr. Dirk U. Duddeck

CleanImplant Foundation
Full Transparency – The Consensus Paper

After intensive work, the Scientific Advisory Board of the CleanImplant Foundation finalized and signed the 20-page consensus document on the "Trusted Quality Mark 2017-2018" in September 2017. In addition to the detailed process description for the analysis of implants – from unpacking under cleanroom conditions to element analysis according to DIN ISO / IEC 17025 – the document also contains a report on numerous examples of various impurities. The definition of criteria by which implants are eligible to bear the quality label is essentially based on this compilation.

The document demonstrates the complete transparency of the CleanImplant evaluation process and is available for download as PDF here.


Consensus Paper -> PDF Download

CleanImplant "Trusted Quality Awards 2017-2018"

Since October 2017, five types of implants from five different manufacturers have gone through the complex analysis and peer review process of CleanImplant. At the EAO meeting in Madrid, the first two implants were awarded the "Trusted Quality" certificate:
BTI with the UniCa surface and the NucleOSS implant T6.

Not long after, at the 13th International MegaGen Symposium in Tokyo, Dr. Kwang-Bum Park, dentist and CEO also received the "Trusted Quality" certificate for the MegaGen AnyRidge implant.

Then again, at the ImplantExpo in Düsseldorf, Germany, the NDI AG was granted the same certificate for its REPLICATE system.

Looking forward, MIS Implant Technologies will receive the certificate for the V3 implant (see image on the right) in February at the next AO meeting in Los Angeles. Further implants’ certifications will follow in 2018.


More information and images of these implants here...

New Member in the Scientific Advisory Board

We are proud to welcome Dr. Scott D. Ganz as the first US American on the global CleanImplant Project Scientific Advisory Board. He has not only made a name for himself as a speaker at numerous congresses but also as assistant editor of the peer-reviewed journal "Implant Dentistry". When we met at the Greater New York Dental Meeting in December 2017, he did not hesitate for a second to join our Board.
We are excited to have Dr. Ganz as a new member on the board of the CleanImplant Foundation, as the complex tasks and goals we set for ourselves for the next years could not be accomplished without his expertise and those of his colleagues on the board.


More information about the Scientific Advisory Board here...

Relaunch of a worldwide Quality Assessment

Following the analysis of over 250 sterile packaged implants in a scanning electron microscope in three consecutive studies over the past decade, we started the new phase of what is probably the world's largest quality assessment of dental implants - using high-resolution SEM images and elemental analyses of the implant surfaces.

The Implant Study 2017-2018 "On Cleanliness of Sterile Dental Implants - A Global Quality Assessment of Implant Surfaces by SEM / EDS Analysis" is carried out in collaboration with the Charité University Medicine Berlin and the University of Gothenburg.

First results are expected in the spring of 2018. Selected analyses’ results will not only be published in scientific journals, but can also be viewed shortly after on the CleanImplant Foundation´s website.


Request for Cooperation

We are often asked by colleagues if it were possible to examine the implants used in their practice. As part of the new Implant Study 2017-2018, a large number of implants used in practices will undergo a comprehensive analysis. For this, we will ask over 100 manufacturers for implant samples. In rare cases, we may not receive the samples or may not be able to order regularly. If you would like to support us in collecting the implants to be examined, please send an e-mail to 

STUDY@CLEANIMPLANT.COM

and tell us which implants you are particularly interested in. We are looking forward to receive your feedback – as said before, in a mutual interest for a good cause.

How safe is your implant?

Residues on sterile packaged implants, in particular organic particles from the production or packaging process, are highly suspected of being responsible for an incomplete osseointegration of dental implants or even a loss of bone in the early healing period. Studies from recent years have shown that neither the CE mark nor the FDA clearance can provide a reliable indication of the cleanliness of dental implants. In March 2017, a new initiative was presented at the IDS in Cologne, which is focusing on this topic for the protection of both the users and the patients... 

Read more and download the complete article as PDF here.


Outlook 2018

Like this past year, we will be back at numerous congresses in 2018. If you would like to discuss your questions, concerns and issues with us in person, here is where you can find us on the events currently scheduled

In Amsterdam at the Europerio 9 congress in June 2018 we will invite implant manufacturers from all over the world to our next round-table meeting.
We will also be present in Dubai (ADEEC 2018)  and Los Angeles (AO Annual Meeting 2018).

If these events are not on the list of your planned congress travels, it might be a great opportunity to meet you at the Kitzbühel Snow Symposium in March. At the "KISS" congress in Austria you will receive an update on implant surfaces with current study results. More information about this event here...

In the new year, the extensive Implant Study 2017-2018 will be the focus of our work, but also the analysis of many new implants in the framework of the Trusted Quality Mark – prone to hopefully extend your trust and confidence for having not only sterile but also residue-free implants in use.


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CleanImplant Foundation CIF GmbH
Pariser Platz 4a | 10117 Berlin | Germany

info@cleanimplant.com | www.cleanimplant.com
Managing Director: Dr. Dirk U. Duddeck